FDA Approves BriaCell’s Pivotal Registrational Study Design in Advanced Metastatic Breast Cancer
June 27 2023 - 8:05AM
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT)
(“BriaCell” or the “Company”), a clinical-stage immunotherapy
company driven to fight cancer and improve patients’ lives,
announces that it has received approval from FDA on its pivotal
registrational study design for Bria-IMT™ in combination with a
checkpoint inhibitor in advanced metastatic breast cancer.
FDA has approved the study design, the primary
and secondary endpoints, and patient population in BriaCell’s
upcoming pivotal registration clinical study. The study will
include advanced metastatic breast cancer patients who have
exhausted all other treatment options.
The trial will be a randomized, open-label study
comparing the Bria-IMT™ combination regimen with an immune check
point inhibitor in one arm with treatment of physicians’ choice in
another arm in advanced metastatic breast cancer. A third smaller
arm with the Bria-IMT™ regimen alone will be included in the study
to address FDA’s combination drug assessment requirements. Upon
achieving statistically significant milestones, BriaCell may apply
for full approval of the Bria-IMT™ combination regimen following
the Biologics Licensing Application (BLA) filing process.
“FDA approval of our study design represents a
major milestone towards our goal of making a huge impact in the
lives of advanced metastatic breast cancer patients who have failed
currently approved therapies,” stated Dr. William V. Williams,
BriaCell’s President and CEO.
“We are extremely grateful that the FDA Office
of Oncologic Diseases has approved our strategy and has provided us
with a route to accelerate the development of our novel
immunotherapy in this difficult-to-treat patient population. A
successful study may significantly transform the approach to treat
advanced breast cancer,” added Dr. Giuseppe Del Priore, BriaCell’s
Chief Medical Officer. “We are working closely with FDA to further
accelerate the development of our lead candidate and eventual
market authorization.”
Patient recruitment and dosing will commence in
summer 2023.
About BriaCell Therapeutics
Corp.
BriaCell is a clinical stage immunotherapy
company developing novel treatments that boost the ability of the
body’s own cancer fighting cells to destroy cancer. More
information is available at https://briacell.com/.Safe
Harbor
This press release contains “forward-looking
statements” that are subject to substantial risks and
uncertainties. All statements, other than statements of historical
fact, contained in this press release are forward-looking
statements. Forward-looking statements contained in this press
release may be identified by the use of words such as “anticipate,”
“believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,”
“seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,”
“target,” “aim,” “should,” “will,” “would,” or the negative of
these words or other similar expressions, although not all
forward-looking statements contain these words. Forward-looking
statements, including in relation to (i) the possibility of
accelerated approval, (ii) eligibility of the Bria-IMT™ combination
regimen with a checkpoint inhibitor for BLA filing, (iii) the
ability of the study to achieve statistically significant
improvement in patient survival compared with treatment of
physicians' choice, (iv) eventual market authorization for
BriaCell's lead candidate, and (v) the timing of patient
recruitment and dosing are based on BriaCell’s current expectations
and are subject to inherent uncertainties, risks, and assumptions
that are difficult to predict. Further, certain forward-looking
statements are based on assumptions as to future events that may
not prove to be accurate. These and other risks and uncertainties
are described more fully under the heading “Risks and
Uncertainties” in the Company's most recent Management’s Discussion
and Analysis, under the heading "Risk Factors" in the Company's
most recent Annual Information Form, and under “Risks and
Uncertainties” in the Company's other filings with the Canadian
securities regulatory authorities and the U.S. Securities and
Exchange Commission, all of which are available under the Company's
profiles on SEDAR at www.sedar.com and on
EDGAR at www.sec.gov. Forward-looking statements
contained in this announcement are made as of this date, and
BriaCell Therapeutics Corp. undertakes no duty to update such
information except as required under applicable law.
Neither the Toronto Stock Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the Toronto Stock Exchange) accepts responsibility for
the adequacy or accuracy of this release.
Contact Information
Company Contact:William V.
Williams, MDPresident &
CEO1-888-485-6340info@briacell.com
Media Relations:Jules
AbrahamDirector of Public RelationsCORE
IR917-885-7378julesa@coreir.com
Investor Relations Contact:CORE
IRinvestors@briacell.com
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